Biosimilars in Action at ASH 2018

At the 2018 Annual Society of Hematology (ASH) Annual Meeting, held Dec. 1-4 in San Diego, biosimilars were often top of mind. Within the hematology and oncology space, Rituxan (rituximab), Neupogen (filgrastim) and Neulasta (pegfilgrastim) are currently the most sought-after biologics for developing biosimilars, and the studies presented at the conference were limited to these three blockbuster biologics.

Here are our top three takeaways from this year’s event:

1. Oncologists want to see more data from biosimilar developers before making treatment decisions, especially in therapeutic care. During the session “What Do Biosimilars Mean for Your Practice?”, we observed that biosimilars don’t seem to have a large impact on the oncology landscape just yet. Filgrastim remained the hot topic for biosimilars, but physicians are starting to think about their next steps with rituximab and other therapeutic oncology drugs. According to a survey shown during the presentation, many physicians understand that there’s no significant difference in efficacy demonstrated between a biosimilar and its reference product, but only half of physicians would be open to switching to a biosimilar product immediately. Some physicians would like to see long-term safety and efficacy data to determine whether the biosimilar would be worth using for therapeutic care, although the same physicians are more open to supportive care biosimilar use (for example, filgrastim).

Furthermore, when asked to what extent cost is a barrier for patients accessing recommended biologic therapies, all respondents with patients currently being treated with biologics affirmed some capacity of access barriers. As rituximab’s biosimilar enters the market, it will be interesting to see how physicians’ perceptions of biosimilars evolve as payers begin to dictate costs.

2. The potential to save healthcare costs is dominating the messaging of biosimilar players. Biosimilar developers continue to emphasize the cost savings that can be realized with biosimilar use, according to several studies presented at ASH.

Sandoz emphasized the cost effectiveness of using biosimilars over the next-generation presentations launched by the originators. For chemotherapy-induced neutropenia, the company presented a study arguing that prophylaxis with biosimilar filgrastim (Zarxio) generates substantial savings over the pegfilgrastim on-body injector (Neulasta’s Onpro kit). According to another Sandoz-sponsored study, even though SC Rituxan saves on time and cost vs. IV Rituxan, using an IV rituximab biosimilar can save on cost over the SC version.

An independent study by the Veterans Health Administration showed considerable cost savings achieved by using Granix in VHA sites: 18 (around 80%) of the 23 surveyed sites used Granix as the preferred treatment option for febrile neutropenia among Neupogen, Zarxio, Granix and Neulasta.

3. Biosimilar developers continue to showcase robust clinical data. ASH 2018 was also a platform for biosimilar developers to showcase the similarity of their products with their respective originators. Three different studies demonstrated that Truxima (rituximab biosimilar) is similar to Rituxan in untreated advanced follicular lymphoma, low tumor burden follicular lymphoma and immune thrombotic thrombocytopenic purpura (ITP), respectively. A real-world study, conducted by the National Health Service’s University College London Hospital for an off-label indication for ITP, likely indicates the NHS’s willingness to further cut down its spending on rituximab, even for the indications that are not on the label.

Pfizer presented a study demonstrating equivalent efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of its rituximab biosimilar, PF-05280586 with Rituxan EU. However, physicians were skeptical that the referenced therapy was EU-sourced rather than the U.S.-sourced Rituxan. A switching study conducted by the Canadian Saskatchewan Cancer Agency demonstrated equivalent efficacy of Apotex’s Grastofil after switching patients from Neupogen for stem cell mobilization prior to transplant.

While biosimilar companies have been focusing on brand-to-biosimilar switch, there’s still a lack of clinical trial data proving the safety of biosimilar-to-biosimilar switching. It remains to be seen how oncologists will react to instances of multiple switching for their patients. Moreover, manufacturers have yet to pursue interchangeability status for a biosimilar in therapeutic oncology care. Although having interchangeability status will be used to influence physician perception, its absence is not expected to have a significant impact on the uptake as oncology therapies are prescribed in hospitals and pharmacists have minimal role to play. With a rituximab biosimilar potentially entering the U.S. market in the first half of 2019, it will be interesting to watch how this space evolves as therapeutic oncology biosimilars go to market.

Biosimilars in Action at ASH 2018

At the 2018 Annual Society of Hematology (ASH) Annual Meeting, held Dec. 1-4 in San Diego, biosimilars were often top of mind. Within the hematology and oncology space, Rituxan (rituximab), Neupogen (filgrastim) and Neulasta (pegfilgrastim) are currently the most sought-after biologics for developing biosimilars, and the studies presented at the conference were limited to these three blockbuster biologics.

Here are our top three takeaways from this year’s event:

1. Oncologists want to see more data from biosimilar developers before making treatment decisions, especially in therapeutic care. During the session “What Do Biosimilars Mean for Your Practice?”, we observed that biosimilars don’t seem to have a large impact on the oncology landscape just yet. Filgrastim remained the hot topic for biosimilars, but physicians are starting to think about their next steps with rituximab and other therapeutic oncology drugs. According to a survey shown during the presentation, many physicians understand that there’s no significant difference in efficacy demonstrated between a biosimilar and its reference product, but only half of physicians would be open to switching to a biosimilar product immediately. Some physicians would like to see long-term safety and efficacy data to determine whether the biosimilar would be worth using for therapeutic care, although the same physicians are more open to supportive care biosimilar use (for example, filgrastim).

Furthermore, when asked to what extent cost is a barrier for patients accessing recommended biologic therapies, all respondents with patients currently being treated with biologics affirmed some capacity of access barriers. As rituximab’s biosimilar enters the market, it will be interesting to see how physicians’ perceptions of biosimilars evolve as payers begin to dictate costs.

2. The potential to save healthcare costs is dominating the messaging of biosimilar players. Biosimilar developers continue to emphasize the cost savings that can be realized with biosimilar use, according to several studies presented at ASH.

Sandoz emphasized the cost effectiveness of using biosimilars over the next-generation presentations launched by the originators. For chemotherapy-induced neutropenia, the company presented a study arguing that prophylaxis with biosimilar filgrastim (Zarxio) generates substantial savings over the pegfilgrastim on-body injector (Neulasta’s Onpro kit). According to another Sandoz-sponsored study, even though SC Rituxan saves on time and cost vs. IV Rituxan, using an IV rituximab biosimilar can save on cost over the SC version.

An independent study by the Veterans Health Administration showed considerable cost savings achieved by using Granix in VHA sites: 18 (around 80%) of the 23 surveyed sites used Granix as the preferred treatment option for febrile neutropenia among Neupogen, Zarxio, Granix and Neulasta.

3. Biosimilar developers continue to showcase robust clinical data. ASH 2018 was also a platform for biosimilar developers to showcase the similarity of their products with their respective originators. Three different studies demonstrated that Truxima (rituximab biosimilar) is similar to Rituxan in untreated advanced follicular lymphoma, low tumor burden follicular lymphoma and immune thrombotic thrombocytopenic purpura (ITP), respectively. A real-world study, conducted by the National Health Service’s University College London Hospital for an off-label indication for ITP, likely indicates the NHS’s willingness to further cut down its spending on rituximab, even for the indications that are not on the label.

Pfizer presented a study demonstrating equivalent efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of its rituximab biosimilar, PF-05280586 with Rituxan EU. However, physicians were skeptical that the referenced therapy was EU-sourced rather than the U.S.-sourced Rituxan. A switching study conducted by the Canadian Saskatchewan Cancer Agency demonstrated equivalent efficacy of Apotex’s Grastofil after switching patients from Neupogen for stem cell mobilization prior to transplant.

While biosimilar companies have been focusing on brand-to-biosimilar switch, there’s still a lack of clinical trial data proving the safety of biosimilar-to-biosimilar switching. It remains to be seen how oncologists will react to instances of multiple switching for their patients. Moreover, manufacturers have yet to pursue interchangeability status for a biosimilar in therapeutic oncology care. Although having interchangeability status will be used to influence physician perception, its absence is not expected to have a significant impact on the uptake as oncology therapies are prescribed in hospitals and pharmacists have minimal role to play. With a rituximab biosimilar potentially entering the U.S. market in the first half of 2019, it will be interesting to watch how this space evolves as therapeutic oncology biosimilars go to market.